TESTOSTERONE LEVEL D TESTO D SMX-S F UCH

GUDID B800TESTODSMXSFUCH5

TESTOSTERONE LEVEL D

UTAK LABORATORIES, INC.

Multiple drugs of abuse IVD, control
Primary Device IDB800TESTODSMXSFUCH5
NIH Device Record Key78f374fc-b725-415c-a123-16d88e6296ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameTESTOSTERONE LEVEL D
Version Model NumberTESTO D SMX-S F UCH
Catalog NumberTESTO D SMX-S F UCH
Company DUNS092519016
Company NameUTAK LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com
Phone8888825522
Emailwelovecontrol@utak.com

Device Dimensions

Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800TESTODSMXSFUCH0 [Primary]
HIBCCB800TESTODSMXSFUCH5 [Package]
Contains: B800TESTODSMXSFUCH0
Package: BOX [45 Units]
In Commercial Distribution

FDA Product Code

LASDrug Specific Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-24
Device Publish Date2024-05-16

Devices Manufactured by UTAK LABORATORIES, INC.

B800DAUNEGFV3UVHS5 - DAU NEGATIVE V32024-10-17 DAU NEGATIVE V3
B800DAUPOSFV3UVHS5 - DAU POSITIVE V32024-10-17 DAU POSITIVE V3
B800CDFUL12GALJNC5 - CERTIFIED DRUG FREE URINE2024-10-11 CERTIFIED DRUG FREE URINE
B800VOLHIGHSULH5 - VOLATILES HIGH2024-10-10 VOLATILES HIGH
B800QCA1OFFWHPM5 - DRUGS OF ABUSE QC A LEVEL 1 2024-10-09 DRUGS OF ABUSE QC A LEVEL 1
B800QCA2OFFWHPM5 - DRUGS OF ABUSE QC A LEVEL 22024-10-09 DRUGS OF ABUSE QC A LEVEL 2
B800QCA3OFFWHPM5 - DRUGS OF ABUSE QC A LEVEL 32024-10-09 DRUGS OF ABUSE QC A LEVEL 3
B80090000UFLTI5 - NICOTINE PLUS LEVEL 12024-10-08 NICOTINE PLUS LEVEL 1

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